A Study of Aleglitazar in Combination With Oral Contraceptive Healthy Volunteers

Healthy Volunteer Clinical Trial

Official title:

Single-Center, Randomized, Double-Blind, Placebo Controlled, Crossover Study to Assess the Effect of Aleglitazar on the Pharmacokinetics and Pharmacodynamics of Ethinyl Estradiol and Levonorgestrel as Components of the Oral Contraceptive Microgynon®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01615354
• Other study ID #: BP25559
• Status: Completed
• Phase: Phase 1
• First received: June 6, 2012
• Last updated: November 1, 2016
• Start date: July 2012
• Est. completion date: January 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

This randomized, double-blind, placebo-controlled, cross-over study will assess the effect of aleglitazar on the pharmacokinetics and pharmacodynamics on Microgynon® in healthy volunteers. Volunteers will receive multiple oral doses of aleglitazar in one period; in the other period volunteers will receive placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy female volunteer, 18 to 45 years of age

• Body mass index (BMI) between 18.0 and 29.9 kg/m2

• Body weight at least 55.0 kg

• Non-pregnant, not lactating and not planning pregnancy from screening to 3 months after the last dose of study treatment

• Non-smoker for at least 3 months

Exclusion Criteria:

• Currently active gynecological disorder

• History of amenorrhea within the previous 3 years

• Known or suspected history of estrogen-dependent neoplasia or sex hormone-dependent malignant tumors

• Use of steroid hormone-containing intrauterine device (IUD) or progesterone-release IUD contraceptive within 3 months to screening.

• History of clinically significant disease that could jeopardize the volunteer safety in the study

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• Aleglitazar
Multiple oral doses
• Microgynon®
Multiple oral doses
• Placebo
Multiple oral doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of Levonorgestrel: area under the concentration time curve		pre-dose and up to 24 hours post-dose	No
Primary	Pharmacokinetics of ethinyl estradiol: area under the concentration time curve		pre-dose and up to 24 hours post-dose	No
Secondary	Pharmacodynamics: luteinizing/follicular stimulation hormone concentration		Days 1, 7, 13, 14, 15, 21	No
Secondary	Safety: incidence of adverse events		16 weeks	No